FDA alert

FDA Approves the First RSV Vaccine For Use in United States

Jessica Ganga

The FDA approved the first respiratory syncytial virus (RSV) vaccine for use in the United States to prevent lower respiratory tract disease (LRTD). The vaccine is approved for adults aged 60 years and older.

RSV was considered a contributor to the “triple threat” of viral respiratory infections in children and older adults during the winter of 2022-2023 (along with COVID-19 and influenza). Further, RSV leads to about 6000 to 10,000 deaths among adults aged 65 years and older in the United States each year, according to the press release.

"Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said Peter Marks, PhD, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

The approval follows an ongoing, randomized, placebo-controlled clinical study that examined the safety and efficacy of the vaccine among individuals aged 60 years and older. In total, 12,500 adults received a single dose of the vaccine, while 12,500 participants received placebo. After analysis, researchers found that the vaccine “significantly reduced the risk of developing RSV-associated LRTD by 82.6%” while also reducing the risk of developing severe RSV-associated LRTD by 94.1%.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Dr Marks.

The common adverse effects reported by individuals who received the vaccine were injection site pain, fatigue, muscle pain, headache, and joint pain and stiffness. Further, atrial fibrillation within 30 days of vaccination was reported in 10 patients who received the vaccine and four patients who received placebo.



FDA approves first respiratory syncytial virus (RSV) vaccine. News release. US Food and Drug Administration; May 3, 2023. Accessed May 3, 2023.